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510(k) K132889

FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED APPLICATOR SET (4 MM) by Nucletron B.V. — Product Code JAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2014
Date Received
September 16, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Applicator, Radionuclide, Remote-Controlled
Device Class
Class II
Regulation Number
892.5700
Review Panel
RA
Submission Type

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Other clearances for product code JAQ

  • K251037 — Rectal Applicator (December 19, 2025)
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  • K250289 — Intracavitary/Interstitial System (April 25, 2025)
  • K243939 — Titanium Flexible Geometry FSD Applicator Set (GM11013400) (March 3, 2025)
  • K241764 — Mould Probe MR Safe (January 10, 2025)
  • K242961 — Intraluminal Applicator Set (November 26, 2024)
  • K243045 — “BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002) (November 19, 2024)
  • K241853 — Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve (November 7, 2024)
  • K241965 — Catheter Surface Flap Applicator Set (GM11011830) (October 29, 2024)